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Carbaphen Ped CH (Gil Pharmaceutical Corp)

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SUSPENSION 1 BOTTLE in 1 CARTON (58552-128-02) > 60 mL in 1 BOTTLE Label Information

Complete Carbaphen Ped CH Information

  • Active ingredient (in each 1 mL)

    Chlophedianol HCl 8 mg

    Chlorpheniramine Maleate 1.25 mg

    Phenylephrine HCl 2.5 mg


  • Purpose

    Antitussive

    Antihistamine

    Nasal Decongestant


  • Uses

    Temporarily relieves:

    • cough due to the common cold.
    • runny nose and sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
    • nasal congestion due to the common cold.

  • Warnings

    Do not use
    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. 

    Ask a doctor before use if you have
    • asthma
    • emphysema
    • glaucoma
    • diabetes
    • excessive phlegm (mucus)
    • breathing problems
    • chronic bronchitis
    • persistent or chronic cough
    • cough associated with smoking
    • trouble urinating due to enlarged prostate gland
    • a sodium-restricted diet
    • thyroid disorders
    • heart disease
    • high blood pressure

    Ask a doctor or pharmacist before use if you are
    • taking sedatives or tranquilizers

    When using this product
    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts, or sleeplessness. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • use 5 mL dosing syringe
    • do not exceed 4 doses in 24 hours
    Children 6 to 12 years of age: 1 to 1.5 mL every 6 to 8 hours.
    Children under 6 years of age: Consult a doctor.

  • Other information

    • store at room temperature

  • Inactive ingredients

    banana flavor, benzoic acid, blueberry flavor, citric acid, ethyl alcohol, glycerin, methylparaben, natural masking agent, propylene glycol, propylparaben, sodium citrate, sorbital, sucralose, water, and xanthan gum.


  • Questions?

    Call Gil Pharmaceuticals Corp. at 787-848-9114, Mon.-Fri. 8:00 am to 5:00 pm, EST.


  • Package/Label Principal Display Panel

    Image of Carton - 60 mL

    NDC 58552-128-02

    Carbapen Ped CH®

    New Improved FORMULA!

    ANTITUSSIVE, ANTIHISTAMINE AND NASAL DECONGESTANT PEDIATRIC SUSPENSION

    GREAT BLUEBERRY BANANA FLAVOR

    Sugar Free

    Easier Dosing for Children

    Unique Dispenser for Exact Dosing

    With Spill Guard Dispenser

    Child Resistant Cap

    Each 1 mL contains:

    Chlophedianol HCl...............................8 mg

    Chlorpheniramine Maleate...............1.25 mg

    Phenylephrine HCl.............................2.5 mg

    2 Fl. Oz. (60 mL)


    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00716


  • INGREDIENTS AND APPEARANCE
    CARBAPHEN PED CH 
    chlophedianol hcl, chlorpheniramine maleate and phenylephrine hcl suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-128
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 8 mg  in 1 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1.25 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BLUEBERRY, BANANA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-128-02 1 in 1 CARTON
    1 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/29/2012
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 833205789 MANUFACTURE(58552-128)